Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT06594068
Brief Summary:
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PRIMULA Lac) is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements. The study will collect data about the presence of anifrolumab in human breast milk and serum (maternal and infant) among lactating individuals who receive anifrolumab therapeutically.
Detailed Description:
PRIMULA Lac is an open-label, open enrollment, post marketing study to assess concentrations of anifrolumab in breast milk and serum in lactating individuals who are receiving anifrolumab therapeutically, and to evaluate exposure on the breastfed infant. Milk collection will occur at a series of 14 timepoints. Maternal serum will be collected Day 1 (pre-dose and 0-4 hours post-dose), Day 12, and approximately Day 29 (immediately preceding subsequent dose). Infant serum will be collected on approximately Day 30 following the next dose and after 24 hours of breast feeding. Maternal and infant adverse events (AEs) will be actively collected for the duration of the study. Total duration of participation for each participant will be approximately 1 month. The objective of this lactation study is to assess presence of anifrolumab in breast milk and serum (maternal and infant) among lactating individuals who receive anifrolumab therapeutically and to evaluate exposure in the breastfed infant. This is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements.
Study:
NCT06594068
Study Brief:
Protocol Section:
NCT06594068